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Nintendo WII and Exercises at Rehabilitation of Individuals With Parkinson's Disease

Efficacy of Nintendo WII and Exercises at Rehabilitation of Individuals With Parkinson's Disease: Randomized Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03235284
Enrollment
45
Registered
2017-08-01
Start date
2015-08-01
Completion date
2017-08-31
Last updated
2019-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Parkinson's Disease ande Video Games

Brief summary

Patients with Parkinson's disease present motor dysfunctions such as stiffness, tremor, postural instability and bradykinesia, which leads to alterations of balance, necessitating specialized physiotherapeutic treatment. In this way this study aims to determine the effectiveness of two tools used in physiotherapy, kinesiotherapy and the Nintendo Wii. 45 patients will be evaluated through the Berg Balance Scale, Dynamic Gait Index, Timed up and go and PDQ-39, and will then be randomized to receive 16 sessions of Exercises or Nintendo Wii alone or together. After this period the patients will be reassessed to verify the effects of the techniques.

Detailed description

Patients with Parkinson's disease present motor dysfunctions such as stiffness, tremor, postural instability and bradykinesia, which leads to alterations of balance, necessitating specialized physiotherapeutic treatment. In this way this study aims to determine the effectiveness of two tools used in physiotherapy, kinesiotherapy and the Nintendo Wii. 45 patients will be evaluated through the Berg Equilibrium Scale, Evaluated by the Dynamic Gait Index and the Timed up and go and PDQ-39. Later patients will be randomized to receive 16 sessions of Kinesiotherapy or Nintendo Wii alone or together, twice a week, for 50 minutes at the Neurociencias Outpatient Clinic of Teacher Magalhães Neto - FUBA. After this period the patients will be reassessed to verify the effects of the techniques.

Interventions

OTHERExercises

A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training

Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game

OTHERExercises and Nintendo Wii

In GCW program will be performed 20 minutes GC protocol (1 or 2, used alternately between sessions a week) and 20 minutes GW protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols

Sponsors

Federal University of Bahia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Single Blind (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Age between 40 and 80 years, * Stage 1 to 3 on the Hoehn and Yahr scale, * Absence of visual or auditory impairment,

Exclusion criteria

* Presence of cognitive alterations according to MEEM: illiterate 19 points; 1 to 3 years of schooling 23 points; 4 to 7 years 24 points and above 7 years of 28 points * Presence of other neurodegenerative diseases, * Uncontrolled osteomioarticular or chronic diseases * Participation in other rehabilitation programs.

Design outcomes

Primary

MeasureTime frameDescription
Berg Balance Scale8 weeksIt is a scale that allows a functional assessment of the balance of the performance. It is based on 14 common items of everyday life, graduated from 0 to 4 points, reaching 56 points maximum score. It presents test reliability and re-test of 98%, another particularity of the scale is the non-linear relationship between the score and the risk of corresponding falls. The scores range from 0 to 56, the higher the score, the better the assessed individual's balance. Each point less on the scale corresponds to an increased risk of falls; between scores 56 to 54, each minus point is associated with a 3 to 4% increase in the risk of falls; between 54 and 46 an increase of 6 to 8% of chances for each point, being that below 36 points the risk of falls is almost 100%

Secondary

MeasureTime frameDescription
Dynamic Gait Index - DGI8 weeksIt is a scale that allows a functional assessment of the balance of the performance. Comprising 8 tasks with a score ranging from 0 to 3 points, maximum score of 24 points and minimum score of 0 points It consists of eight tasks involving walking in different sensory contexts, which include flat surface, change in gait speed, horizontal and vertical head movements, overpassing and bypassing obstacles, turning over the body axis itself, going up and down stairs . The maximum score is 24 points, and a score of 19 points or less predicts risk of falls. The scale has no gaps, only cutoff points. The higher the value, the better the gait performance. For patients with Parkinson's disease, values below 19 points predict major gait problems and high risk of falls.
Timed Up and Go - TUG8 weeksThe TUG measures, in seconds, the time it takes an individual to lift from a standard armchair (height of approximately 46 cm), walk a distance of 3 meters, turn, walk back to the chair and sit again. The patient is asked to lift from a chair (seat height of 45 cm and arms from 65 cm) to walk 3 meters, return and sit again, while the time spent in performing this task is timed. TUG up to ten seconds - individual without change of balance and with low risk of falls; (2) TUG between 11 and 20 seconds - individual with no significant alteration of balance, but presenting some fragility and medium risk of falls; (3) TUG greater than 20 seconds and less than 30 seconds - individual in need of intervention; (4) TUG greater than 30 seconds - individual at high risk for falls and with impaired mobility
Parkinson's Disease Questionnaire (PDQ-39)8 weeks39 items divided into 8 domains. The total score ranges from 0 to 100, in which a lower score denotes a better perception of the patient's. It is divided into eight categories: mobility (10 items), daily life activities (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (3 items) and body discomfort (3 items) .43 The score ranges from 0 (no problem) to 100 (maximum problem level), ie low score indicates the individual's perception of a better quality of life .. These items can be grouped into three domains: physical, mental and social. The score is made by rule of three and transformed into values from 0 to 100, and higher values refer to poorer quality of life.

Countries

Brazil

Participant flow

Participants by arm

ArmCount
Exercises
A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training;
14
Nintendo Wii
Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game
13
Exercises and Nintendo Wii
Exercises and Nintendo Wii: A program of therapeutic exercises (GC) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). The GC treatment program consists of the following protocols: a) protocol 1 : 30 minutes diagonal exercise upper limb, 10 minutes diagonal exercise scapula and 20 minutes 20 minutes of extension exercises for the trunk; b) protocol 2: 20 minutes diagonal exercise lower limb,10 minutes diagonal exercise pelvis, and 10 minutes gait cycle training. Nintendo Wii program (GW) for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions). Protocol 1 games (Boxing e Soccer); b) protocol 2 games (Golf and Running). In GCW program will be performed 20 minutes G0 protocol (1 or 2, used alternately between sessions a week) and 20 minutes G1 protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols.
14
Total41

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyAdverse Event121

Baseline characteristics

CharacteristicExercisesNintendo WiiExercises and Nintendo WiiTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
10 Participants10 Participants10 Participants30 Participants
Age, Categorical
Between 18 and 65 years
4 Participants3 Participants4 Participants11 Participants
Age, Continuous64.5 years
STANDARD_DEVIATION 9.8
61.7 years
STANDARD_DEVIATION 7.3
66.6 years
STANDARD_DEVIATION 8.2
64.2 years
STANDARD_DEVIATION 8.3
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
10 Participants10 Participants10 Participants30 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
4 Participants3 Participants4 Participants11 Participants
Sex: Female, Male
Female
3 Participants2 Participants5 Participants10 Participants
Sex: Female, Male
Male
11 Participants11 Participants9 Participants31 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 140 / 130 / 14
other
Total, other adverse events
0 / 140 / 130 / 14
serious
Total, serious adverse events
0 / 140 / 130 / 14

Outcome results

Primary

Berg Balance Scale

It is a scale that allows a functional assessment of the balance of the performance. It is based on 14 common items of everyday life, graduated from 0 to 4 points, reaching 56 points maximum score. It presents test reliability and re-test of 98%, another particularity of the scale is the non-linear relationship between the score and the risk of corresponding falls. The scores range from 0 to 56, the higher the score, the better the assessed individual's balance. Each point less on the scale corresponds to an increased risk of falls; between scores 56 to 54, each minus point is associated with a 3 to 4% increase in the risk of falls; between 54 and 46 an increase of 6 to 8% of chances for each point, being that below 36 points the risk of falls is almost 100%

Time frame: 8 weeks

ArmMeasureGroupValue (MEAN)Dispersion
ExercisesBerg Balance ScaleAfter45.6 Score on a scaleStandard Deviation 5.4
ExercisesBerg Balance ScaleBefore40.5 Score on a scaleStandard Deviation 5.6
Nintendo WiiBerg Balance ScaleBefore43.9 Score on a scaleStandard Deviation 5.3
Nintendo WiiBerg Balance ScaleAfter49.2 Score on a scaleStandard Deviation 4.4
Exercises and Nintendo WiiBerg Balance ScaleAfter47.1 Score on a scaleStandard Deviation 5.4
Exercises and Nintendo WiiBerg Balance ScaleBefore41.6 Score on a scaleStandard Deviation 5.9
Secondary

Dynamic Gait Index - DGI

It is a scale that allows a functional assessment of the balance of the performance. Comprising 8 tasks with a score ranging from 0 to 3 points, maximum score of 24 points and minimum score of 0 points It consists of eight tasks involving walking in different sensory contexts, which include flat surface, change in gait speed, horizontal and vertical head movements, overpassing and bypassing obstacles, turning over the body axis itself, going up and down stairs . The maximum score is 24 points, and a score of 19 points or less predicts risk of falls. The scale has no gaps, only cutoff points. The higher the value, the better the gait performance. For patients with Parkinson's disease, values below 19 points predict major gait problems and high risk of falls.

Time frame: 8 weeks

ArmMeasureGroupValue (MEAN)Dispersion
ExercisesDynamic Gait Index - DGIBefore15.6 Units on a scaleStandard Deviation 4.7
ExercisesDynamic Gait Index - DGIAfter17.6 Units on a scaleStandard Deviation 3.6
Nintendo WiiDynamic Gait Index - DGIBefore15.7 Units on a scaleStandard Deviation 2.9
Nintendo WiiDynamic Gait Index - DGIAfter19 Units on a scaleStandard Deviation 3.1
Exercises and Nintendo WiiDynamic Gait Index - DGIBefore15.8 Units on a scaleStandard Deviation 1.9
Exercises and Nintendo WiiDynamic Gait Index - DGIAfter19.5 Units on a scaleStandard Deviation 2.2
Secondary

Parkinson's Disease Questionnaire (PDQ-39)

39 items divided into 8 domains. The total score ranges from 0 to 100, in which a lower score denotes a better perception of the patient's. It is divided into eight categories: mobility (10 items), daily life activities (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (3 items) and body discomfort (3 items) .43 The score ranges from 0 (no problem) to 100 (maximum problem level), ie low score indicates the individual's perception of a better quality of life .. These items can be grouped into three domains: physical, mental and social. The score is made by rule of three and transformed into values from 0 to 100, and higher values refer to poorer quality of life.

Time frame: 8 weeks

ArmMeasureGroupValue (MEDIAN)
ExercisesParkinson's Disease Questionnaire (PDQ-39)After25.7 Score on a scale
ExercisesParkinson's Disease Questionnaire (PDQ-39)Before32.7 Score on a scale
Nintendo WiiParkinson's Disease Questionnaire (PDQ-39)Before37.1 Score on a scale
Nintendo WiiParkinson's Disease Questionnaire (PDQ-39)After29.7 Score on a scale
Exercises and Nintendo WiiParkinson's Disease Questionnaire (PDQ-39)After23.5 Score on a scale
Exercises and Nintendo WiiParkinson's Disease Questionnaire (PDQ-39)Before32.9 Score on a scale
Secondary

Timed Up and Go - TUG

The TUG measures, in seconds, the time it takes an individual to lift from a standard armchair (height of approximately 46 cm), walk a distance of 3 meters, turn, walk back to the chair and sit again. The patient is asked to lift from a chair (seat height of 45 cm and arms from 65 cm) to walk 3 meters, return and sit again, while the time spent in performing this task is timed. TUG up to ten seconds - individual without change of balance and with low risk of falls; (2) TUG between 11 and 20 seconds - individual with no significant alteration of balance, but presenting some fragility and medium risk of falls; (3) TUG greater than 20 seconds and less than 30 seconds - individual in need of intervention; (4) TUG greater than 30 seconds - individual at high risk for falls and with impaired mobility

Time frame: 8 weeks

ArmMeasureGroupValue (MEAN)Dispersion
ExercisesTimed Up and Go - TUGAfter8.2 SecondsStandard Deviation 2.5
ExercisesTimed Up and Go - TUGBefore10.7 SecondsStandard Deviation 3.6
Nintendo WiiTimed Up and Go - TUGBefore11.5 SecondsStandard Deviation 5.1
Nintendo WiiTimed Up and Go - TUGAfter8.5 SecondsStandard Deviation 2.1
Exercises and Nintendo WiiTimed Up and Go - TUGBefore13.9 SecondsStandard Deviation 2.5
Exercises and Nintendo WiiTimed Up and Go - TUGAfter10.6 SecondsStandard Deviation 2.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026